Last updated: February 8, 2022
Sponsor: Sichuan Cancer Hospital and Research Institute
Overall Status: Active - Not Recruiting
Phase
2
Condition
Esophageal Cancer
Squamous Cell Carcinoma
Lung Cancer
Treatment
N/AClinical Study ID
NCT04177797
SCCH-TS2001
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1.Histologically confirmed ESCC;
- 2.Clinical stage T1-2N2-3M0 or T3N1-3M0 or T4N0-3M0(AJCC 8 TNM classification);
- 3.Have a performance status of 0 or 1 on the ECOG Performance Scale;
- 4.The important organs functions meet the following requirements:the absoluteneutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L;bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
- 5.Expected survival time is greater than or equal to 3 months;
- 6.Female subjects of childbearing potential should have a negative urine or serumpregnancy within 72 hours prior to receiving the first dose of study medication. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancy testwill be required;
- 7.Female subjects of childbearing potential must be willing to use an adequate methodof contraception - Contraception, for the course of the study through 90 days afterthe last dose of study medication;
- 8.Be willing and able to provide written informed consent/assent for the trial.
Exclusion
Exclusion Criteria:
- 1.Has any active autoimmune disease or a history of autoimmune disease;
- 2.The patient is receiving systemic steroid therapy or any other form ofimmunosuppressive therapy;
- 3.The patient had active infection, fever of unknown cause ≥38.5℃ within 7 days beforethe medication, or white blood cell count at baseline >15×109/L;
- 4.The patient had previously received other anti-pd-1 antibody therapy or otherimmunotherapy targeting pd-1 / pd-L1,or received chemoradiotherapy;
- 5.Have a history of mental illness or psychiatric substance abuse;
- 6.Patients who had participated in clinical trials of other drugs within 4 weeks;
- 7.Patients with a serious risk to treating patients' safety or a concomitant diseasethat affects the completion of the study according to the researchers judgment;
- 8.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;
- 9.Other patients whom the medical practitioner considers inappropriate for inclusion.
Study Design
Total Participants: 20
Study Start date:
March 20, 2020
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan 610041
ChinaSite Not Available

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